MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR PROLONG 40MM BRNG STD; PROSTHESIS, SHOULDER

Catalog Number	110031421
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Procode: phx.Concomitant medical devices: unk humeral tray cat#: ni, lot#: ni.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00420.
Event or Problem Description
It was reported patient underwent a revision procedure approximately one month post implantation due to dislocation.During the revision procedure, the surgeon noticed that the poly was no longer attached to the tray which was why the shoulder had dislocated.Poly was revised.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10 visual examination of the returned product identified: the cr prolong 40mm brng std exhibits a heavy indentation and backside wear marks.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CR PROLONG 40MM BRNG STD
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11337822
• Report Number: 0001822565-2021-00419
• Device Sequence Number: 2671854
• Product Code: PHX
• UDI-Device Identifier: 00887868231520
• UDI-Public: (01)00887868231520(17)241031(10)64489337
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: 110031421
• Device Lot Number: 64489337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention